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HepB mAb19 for Chronic Hepatitis B Infection

This study is testing a new treatment called HepB mAb19 for people with chronic hepatitis B (CHB). HepB mAb19 is a monoclonal antibody, a type of protein that helps your immune system fight off infections. Researchers want to see how safe HepB mAb19 is and how well your body handles it. They are also looking at its effects on the hepatitis B virus. You might be able to join if you are 18 to 70 years old, have had chronic hepatitis B for at least six months, and are already taking medication for it. Your hepatitis B DNA levels must be very low, and your HBsAg (a marker of the virus) must be above 10 IU/mL. The study aims to enroll 37 participants. The current status of this study is unclear.

Study design
This is a first-in-human, placebo-controlled study with increasing doses. Participants will be randomly assigned to receive either HepB mAb19 or a placebo (sterile saline).
What's involved
You will receive a single intravenous infusion of HepB mAb19 or placebo. You will be followed for 48 weeks after the infusion, with check-ups at 2, 12, 24, and 48 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 48 weeks after receiving the study treatment or placebo.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05856890

HepB mAb19 in Individuals With Chronic Hepatitis B Infection

Recruiting
PHASE1Ages 18–70InterventionalTreatment
Rockefeller University
~37 participants
Updated 2026-02-02 on ClinicalTrials.gov
What's tested:HepB mAb19Sterile Saline

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate and severity of solicited adverse events that are Grade 2 or above within 2 weeks after administration.
Measured over 2 weeks
+13 more outcomes measured

Conditions

Hepatitis b Virus
Hepatitis B

Explore related trials

Hepatitis B InfectionHepatitis B InfectionHepatitis B Virus HBsAg Surface Protein Antigen

Where it's being run

2 sites across 1 states
New York2

Study leadership

  • Marina Caskey, MD · PRINCIPAL_INVESTIGATOR · The Rockefeller University

Who to contact

Recruitment Specialist
[email protected]
800-782-2737
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Age 18 to 70;
HBV infection confirmed by positive HBsAg for \>/= 6 months;
On HBV-active nucleos(t)ide therapy for \>/= 6 months without change in NRTI in the previous 3 months;
The following laboratory values within 49 days from study entry (day 0):
HBV DNA below lower limit of quantification;
HBsAg \> 10 IU/mL;
HBs antibody negative;
Ability and willingness to provide informed consent;
For participants who can become pregnant (i.e., participants who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy), negative serum or urine pregnancy test at screening and on day 0 (study entry).
Participants who can become pregnant must agree to use two methods of contraception.
Partner sterilization with documentation of azoospermia prior to the participant's entry into the study, and this partner is the sole partner for that participant. The documentation of partner sterility can come from the site personnel's review of medical records or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents.
Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms from 10 days prior to study entry and during study follow up to avoid impregnating a partner who can get pregnant.

Exclusion

Presence of a LI-RADS4 or 5 liver lesion on imaging within 12 months from entry or done at pre-infusion visit, if prior results not available.
Alpha fetoprotein \> 20 ng/ml Note: AFP above normal but \< 20 is acceptable for entry if earlier AFP levels (older than 6 months) are within normal range and imaging is negative in last 3 months).
HIV-1, HCV or hepatitis delta virus infection within 12 months from entry or done at screen, if prior results not available.
History of hematopoietic stem cell transplant or solid organ transplant;
Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, monoclonal antibody or vaccine, or multiple drug allergies (non-active hay fever is acceptable);
History of cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death);
History or presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., QT corrected for heart rate using the Fridericia's correction factor \[QTcF\] \> 450 ms for males and QTcF \> 470 ms for females);
History of systemic corticosteroids, immunosuppressive anti-cancer, systemic interferons or interleukins within the last 6 months;
History of chronic liver disease from another cause, immune complex disease, or autoimmune diseases that in the opinion of the investigator would preclude participation.
Any significant acute infection (e.g. influenza, COVID-19) or any other clinically significant illness within 2 weeks prior to Day 0.
Laboratory abnormalities in the parameters listed below:
Absolute neutrophil count \< 1,000 /mm3
Hemoglobin \< 10 gm/dL
Platelet count \< 150,000 /mm3
ALT \> 2.0 x ULN
AST \> 2.0 x ULN
Total bilirubin \> 1.5 ULN (except individuals with known Gilbert's)
Albumin \< 3.5 gm/dL
Calculated creatinine clearance \< 70 mL/min (using the Cockcroft Gault formula).
INR \>/= 1.2
Pregnancy or lactation;
Any vaccination within 14 days prior to IP administration;
Receipt of anti-HBV mAb therapy of any kind in the past (including HBIG);
Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.

What this trial measures

  • Rate and severity of solicited adverse events that are Grade 2 or above within 2 weeks after administration.2 weeks

    The occurrence of solicited AEs will be assessed 2 weeks after IP administration.

  • Rate and severity of treatment-emerging unsolicited adverse events that are Grade 2 or above (including confirmed laboratory abnormalities) within 2, 12, 24 and 48 weeks after administration.48 weeks

    The occurrence of treatment-emerging AEs will be assessed after IP administration

  • Rate and severity of participants with serious adverse events (SAEs) throughout the study period that are considered related to investigational product and the duration of those SAEs.48 weeks

    The occurrence of SAEs will be assessed after IP administration

  • Rate and severity of participants with potential immune complex disease (ICD) throughout the study period following investigational product (IP) administration.48 weeks

    The occurrence of immune complex disease will be assessed after IP administration

  • Changes in AST within 2,12, 24 and 48 weeks after administration.48 weeks

    Changes in AST will be assessed after IP administration

  • Changes in ALT within 2,12, 24 and 48 weeks after administration48 weeks

    Changes in ALT will be assessed after IP administration

  • Changes in alkaline phosphatase within 2,12, 24 and 48 weeks after administration48 weeks

    Changes in alkaline phosphatase will be assessed after IP administration

  • Changes in bilirubin within 2,12, 24 and 48 weeks after administration48 weeks

    Changes in bilirubin will be assessed after IP administration

  • Changes in albumin within 2,12, 24 and 48 weeks after administration48 weeks

    Changes in albumin will be assessed after IP administration

  • Elimination half-life of HepB mAb1948 weeks

    Elimination half-life (t1/2) will be assessed after IP administration

  • Clearance (CL/F) of HepB mAb1948 weeks

    Clearance (CL/F) will be assessed after IP administration

  • Volume of Distribution (Vz/F) of HepB mAb1948 weeks

    Volume of Distribution (Vz/F) will be assessed after IP administration

  • Area under the curve (AUC) of HepB mAb1948 weeks

    Area under the curve (AUC) will be assessed after IP administration

  • Decay Curve of HepB mAb1948 weeks

    Decay Curve will be assessed after IP administration